Last week during Natural Products Expo West, a dynamic discussion of DSHEA (Dietary Supplement Health and Education Act of 1994) painted the act's legal guidelines in a positive light. Offering practical and even fun (yeah, you read it right, fun) ways to remain sane and in compliance, herbalist and educator, Trinity Ava, alongside Carol Nicholson, RN, president and founder of International Marketing Company, tailored their talk to the mostly retailer audience.
Ava even played a little game, acting the part of retail employee and challenging seminar attendees to stump her with common supplement-related questions from a customer standpoint. No one did. She nailed each response by being careful not to repeat disease claims back to the customer and using phrasing like "this supports immune health" to get around any language that might get your store flagged by FDA.
Here are five of their most important presentation points for how to operate within the DSHEA framework to guide you through truly helping your customers without hindering your reputation with the FDA.
1. What you can't say
Do not discuss a disease state as it relates to a food or supplement, and generally avoid "heals, cures, relieves," along with all diseases and conditions. Cold and flu prevention in particular are a major target of late. A few of the non-compliant disease claims that were flagged include:
- Powerful cold and flu defense
- Taken at the first sign of a cold or flu symptom
- Taken throughout the cold season as an effective preventative
- Available in the Cough & Cold Section
- Boost your immune system and fight cold and flu
- Single most powerful formula to help guard your health
- Most effective alternative to the flu shot
2. Tread even lighter
Hot-button areas are as follows:
- Immune support
- Heart health
- Weight management
- Blood glucose levels
- Children’s products
- Dermal health and topicals (yes, the FDA monitors these)
3. Retailer compliance
In addition to manufacturers and online stores, flagrant violations even extend to what retail employees say to customers, as they too are legally required to abide by DSHEA. Though not as common, retailers do get FDA warning letters, especially when their materials and websites:
- Recommend products for specific diseases/conditions
- Give overt medical advice
- Tout specific natural products as alternatives to FDA-approved pharmaceuticals
4. Good news!
There's a lot more to what you can say than what you should avoid—it just means getting creative with verbiage. Structure/function claims are encouraged. Use phrasing like:
- Promotes/supports healthy ______
- Supports the skin’s healthy rejuvenation (if marketing toward a consumer)
- Supports leukocyte health and function (if marketing toward a physician)
- What's more, you can openly talk about conditions that aren't disease related, i.e. menopause, PMS, occasional acne, stress, etc.
- Supplements in the homeopathic arena constitute a safe zone of sorts, as they're in a separate category outside of DSHEA and allowed to make drug and disease-like claims. For instance, Zicam can make cold claims per the homeopathic pharmacopeia.
Say this, not that. Reworking non-compliant claims*
- Instead of: Reduces blood pressure Say: Supports healthy blood pressure levels already in the normal range
- Instead of: Promotes fast recovery from athletic injuries Say: Promotes athletic recovery
- Instead of: Improves blood circulation to the brain Say: Supports healthy micro-circulation/promotes healthy circulation to the brain
- Instead of: Soothes food allergies Say: Promotes healthy digestive and immune system function
- Instead of: Prevents insomnia Say: Promotes healthy, restful sleep
- Instead of: Get over your cold faster Say: Support a healthy immune system during times of seasonal challenge
- "A good source of electrolytes" is only compliant if a serving contains at least 10 percent of the RDI Say: Provides trace amounts of key electrolytes
*Open to legal interpretation.
5. All things branded
Compliance extends to everything surrounding a brand, including:
- Print materials/ads
- Facebook, Twitter and other social media platforms
- Customer testimonials
- Retailer/Employee education materials (you can be a little more open here, but still no disease claims)
- Product manufacturers’ level of compliance (both packaging text and quality standards)
Materials are only considered an extension of a brand if it has that brand on it. Accordingly, manufacturers and retailers can use third-party literature to make claims. For example, a doctor or well-known industry professional can author literature that covers all the details so that the story is told without the manufacturer saying a word.
Retailers can sell and point customers to such books, newsletters, peer reviews, white papers, booklets, etc. so long as their lit section lives at least 100 feet from the supplements. On a website, this information must be at least two clicks away.
Nicholson also advises all retailers to employ a licensed nutritionist/dietician, and Ava encourages stores to act as one-stop shop of information for their customers—as well as a hub to support the whole person's health for clinicians and schools in the area.
Apps, kiosks and printed materials are additional resources at your disposal for more authoritative information to address the diseases of our day. Some websites to help you stay educated include: