Amid weak regulation, consumer activism needed
The FDA has the powers but not enough resources to implement them
By Leilani Chavez
Newsbreak’s Maggie de Pano fellow
As early as 2008, some groups and individuals have filed mislabeling complaints before the Food and Drug Administration against glutathione brands such as MET Tathione and Lucida-DS.
According to lawyer Donna Sanchez of FDA’s regulations division, majority of the FDA cases against glutathione brands involve mislabeling, misleading advertisements, and health claims. As food supplements, glutathione capsules are forbidden from being marketed as drugs or cosmetics. Thus, ads claiming that the use of glutathione can whiten complexion and cure certain diseases are against the law.
The Department of Health however only puts under surveillance the marketing and use of glutathione injectibles, which it considers high-risk. [Glutathione injectibles are classified as drugs, unlike their capsule counterparts that are placed under food supplements.]
How come the firms behind glutathione capsules get away with it?
One obvious reason is that there is no specific law that oversees the glutathione industry or the entire food supplements industry for that matter. Since 1968, regulations on food supplements are based only on certain administrative orders. Perhaps the most significant of these orders is the one handed down in 1992, which required additional labeling of “No Approved Therapeutic Claims” in food supplements whose health benefits are still questionable.
It was only in 2004, when food supplements were freely entering the market through direct selling, that the government introduced the registration and regulation food supplements.
Still, the entire industry remains under the radar.
‘Regulate your greed’
The regulation of the glutathione industry rests on the shoulders of the FDA. But the agency can only order product recalls.
Every now and then, the FDA does post-market surveys (PMS). It involves getting random sample products and putting them under laboratory testing. This is done year-round and covers all categories.
But the FDA’s random sampling depends on complaints from consumers or in-house inspectors for certain product that is not in the red light category, like glutathione capsules.
In 2008, the FDA recalled three glutathione brands: Lucida-DS, Vaniderm, and Glutalife, when it was reported that the capsules contained lesser gluta content as advertised.
Tests that followed showed that these capsules contained less glutathione milligrams than what was indicated in the label. Sanchez recalls that Lucida-DS and Vaniderm distributor United Shelter Health Philippines (USHP) argued their case by saying that one batch was problematic and that the other bottles had the proper glutathione levels.
At that time, USHP president Melinda Galindez explained that these were beyond their control since they only repackaged the capsules. “We’re only distributors,” she had said.
This seems a convenient way out for distributors since for the longest time, they were not the ones who sought FDA approval but their manufacturers abroad. “Mahirap i-regulate ang industry pero kailangan,” says Ronald De Veyra, FDA deputy-director. “It’s natural for industries to protect itself pero regulate your greed.”
It was only recently that the FDA issued a new regulation requiring distributors as well to seek approval for the products that they are marketing. The new rule covers the entire food industry–including glutathione capsules.
Lacking resources, manpower
Beyond these issues, the FDA is hampered by the usual problem besetting a Philippine government agency: equipped with powers but without enough resources to implement them.
RA 9711, which restructured the FDA and granted it wider powers, renamed the Bureau of Food and Drugs into FDA. It mandates the establishment of “adequate testing laboratories and field offices across the country,” the upgrade of its equipment, increase in manpower and the “authority to retain its income.”
RA 9711 also allows the creation of a Regulatory Enforcement Unit (REU) for five years starting 2008. The unit is to be composed of five people in every region. This unit can execute search and arrest warrants against erring companies.
Government data show that there has been a notable increase in the allotment for the regulations of food and drugs–from P125.7 million in 2007 to P217.3 million in 2011. But this is still shared with other programs like food fortification and salt iodization.
In terms of manpower, the agency only has more than 50 inspectors in the National Capital Region (NCR) and one inspector per province. This is insufficient considering the number of industries that require FDA oversight.
The FDA is required to look into retail, manufacturing, and drugstores, including markets. The agency needs more people to do be able to perform this function. “We need more inspectors na magmo-monitor ng industry. Manpower talaga ang problema. Ideally,dapat may enforcement unit na kapag may order, isasasarado (ang company),tapos ipa-padlock. Siguro eventually aabot sa ganito angimplementation, ang enforcement,” De Veyra said.
As of now, the FDA depends on existing policies and procedures to regulate the burgeoning food supplements industry.
Food supplements fall under the food category. Unlike drugs, the approval process is relatively easier. The FDA has different standards for food, drugs, and cosmetics with the approval for drugs requiring the most stringent procedures.
Food products are mostly checked for toxic contents, which companies list down after filing their applications in the product services division of the FDA.
The FDA checklist for food supplement application includes:
- List of ingredients in order of proportion
- Sample label
- Manufacturing method
- Certificate of Analysis from recognized laboratories
- Safety index (absence of synthetic substances)
De Veyra explains that food supplements fall under the food category “since they have no claims of clinical studies, but they are checked for lethal food additives and toxic substances.” Approval procedure for food supplements is not that strict.
Once a product is approved, the approval can cover a period of two to five years. After that, companies need to re-apply. Food supplements, however, are required to re-apply every two years.
The process is long but the fees are cheap. Companies only need to pay P1,000 for initial registration per year and P200 for re-application. And companies do not pay much when they commit trade sins. The maximum fee for an erring company is P50,000 while the maximum is P500,000.
So far, no company has been punished with the maximum penalty, says FDA.
So how does the FDA then deal with glutathione capsule firms that peddle their products not as an anti-oxidant, as approved, but as a whitening for marketing purposes? For now, the agency is practically helpless about it.
Once a food supplement advertisement comes out, the FDA can only call the attention of a product if it outrightly claims to cure or heal diseases. “Sa mga ads kadalasan may gray areas. Pumapasok ang FDA kapag cases ng false claims like nakakagamot ang isang food supplement. Kapag naman na-air na, (regulations fall) under advertising or broadcasting associations,” FDA’s De Veyra said.
According to Sanchez, regulations head of the FDA, distributors get away with false claims because the FDA allows so-called gray advertising. “There are cases na the verbal message of the ad is antioxidant pero ang packaging niya ay for whitening, na very indirect ang message ng whitener. These are called gray areas. For now, we allow this,” she says.
But regulating the industry should not only depend on government agencies. Consumers should also speak out when they experience side effects caused by glutathione use.
One instructive example was the case of Power Balance, a type of hologram bracelets that purportedly increases “strength, balance, and flexibility” in wearers. The bands claimed that these can improve a user’s athletic performance and were worn by athlete superstars Shaquille O’Neal and David Beckham.
But in December last year, the company issued a statement admitting that the products have no scientific credible evidence and offered refunds. The statement is no longer available in the company website.
It was a consumer commission—the Australian Competition and Consumer Commission—that forced Power Balance to admit that their bands have no credible scientific evidence after a series of advertisements.
Perhaps, a strong consumer group in the Philippines can start the ball rolling.
“Consumers can always file complaints with the FDA,” says De Veyra. “Kapag may nag-file ng complaint sa FDA, we can investigate.”- Newsbreak
Previous stories in this series
(The series was produced under the Maggie de Pano Fund for Investigative Reporting on Health. The Fund, which is managed by Newsbreak, is made possible through a grant from Macare Medicals, Inc.)
TAGS: department of health, Food and Drug Administration, food supplements, glutathione